Commonwealth of Australia	Gazette	
No. APVMA 14, Tuesday, 12 July 2016
Published by The Australian Pesticides  and Veterinary Medicines Authority	Agricultural and Veterinary Chemicals	
Australian Government
	
Australian Pesticides and Veterinary Medicines Authority
The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995. 
The Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be published in the Gazette containing details of the registration of agricultural and veterinary chemical products and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code and related legislation also requires certain other notices to be published in the Gazette. A reference to Agvet Codes in this publication is a reference to the Agvet Code in each state and territory jurisdiction.
ISSN 1837 - 7629
 Commonwealth of Australia 2016
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and inquiries concerning reproduction and rights should be addressed to: 
Director, Public Affairs and Communications
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182 
Kingston ACT 2604 
Email: communications@apvma.gov.au 
Website: www.apvma.gov.au.
General Information
The APVMA (Australian Pesticides and Veterinary Medicines Authority) Gazette is published fortnightly and contains details of the registration of agricultural and veterinary chemicals products and other approvals granted by the APVMA, notices as required by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material issued by the APVMA.
Pursuant to section 8J(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activity in quarterly statistical reports.
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CONTENTS
Agricultural Chemical Products and Approved Labels
Veterinary Chemical Products and Approved Labels
Approved Active Constituents
Cancellation of Registration and Approval at the Request of the Holder
Cancellation of Label Approval at the Request of the Holder
New Agricultural Active Constituent Mandestrobin
New Agricultural Chemical Product Containing a New Agricultural Active Constituent mandestrobin in Intuity Fungicide
Licensing of Veterinary Chemical Manufacturers

Agricultural Chemical Products and Approved Labels 
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.
1.	Agricultural Products Based on New Active Constituents
Application no.:	60590	
Product name:	Aviator Xpro Foliar Fungicide	
Active constituent/s:	75 g/L bixafen, 150 g/L prothioconazole	
Applicant name:	Bayer Cropscience Pty Ltd	
Applicant ACN:	000 226 022	
Summary of use	For the control of blackleg in canola	
Date of registration/approval:	29 June 2016	
Product registration no.:	69361	
Label approval no.:	69361/60590	
2.	agricultural Products Based on Existing Active Constituents
Application no.:	105772	
Product name:	Brandt Adjust 700 Surfactant	
Active constituent/s:	350 g/L soyal phospholipids 350 g/L propionic acid	
Applicant name:	Brandt Consolidated Inc	
Applicant ACN:	N/A	
Summary of use	For acidifying and penetrating surfactant, reducing alkaline hydrolysis of dimethoate, assisting with uptake of foliar fertilisers and assisting in management of spray droplet size	
Date of registration/approval:	16 June 2016	
Product registration no.:	82443	
Label approval no.:	82443/105772	

Application no.:	104791	
Product name:	CGS Prep 720 Growth Regulator	
Active constituent/s:	720 g/L ethephon (an anticholinesterase compound)	
Applicant name:	Cotton Growers Services Pty Ltd	
Applicant ACN:	001 723 048	
Summary of use	For accelerated boll opening and pre-conditioning before defoliation of cotton	
Date of registration/approval:	20 June 2016	
Product registration no.:	82011	
Label approval no.:	82011/104791	

Application no.:	105048	
Product name:	Adama MCPA 750 SL Herbicide	
Active constituent/s:	750 g/L MCPA present as the dimethylamine salt	
Applicant name:	Adama Australia Pty Limited	
Applicant ACN:	050 328 973	
Summary of use	For the control of broadleaf weeds in cereals, linseed, pastures, rice, sugar cane and turf	
Date of registration/approval:	20 June 2016	
Product registration no.:	82118	
Label approval no.:	82118/105048	
Application no.:	105707	
Product name:	Relyon Caboose 500SC Fungicide	
Active constituent/s:	500 g/L carbendazim	
Applicant name:	Ruralco Holdings Limited	
Applicant ACN:	009 660 879	
Summary of use	For the control of fungal diseases in various crops	
Date of registration/approval:	21 June 2016	
Product registration no.:	82417	
Label approval no.:	82417/105707	

Application no.:	106140	
Product name:	Double Alpha Isoxaflutole 750 WG Herbicide	
Active constituent/s:	750 g/kg isoxaflutole	
Applicant name:	Alpha Crop Protection Pty Ltd	
Applicant ACN:	165 653 047	
Summary of use	For the control and suppression of various broadleaf weeds and grasses in sugarcane and chickpeas	
Date of registration/approval:	21 June 2016	
Product registration no.:	82590	
Label approval no.:	82590/106140	

Application no.:	105606	
Product name:	Titan Imazapic 240 Herbicide	
Active constituent/s:	240 g/L imazapic present as the ammonium salt	
Applicant name:	Titan AG Pty Ltd	
Applicant ACN:	122 081 574	
Summary of use	For the pre-emergence control of certain annual grass and broadleaf weeds in fallow situations, sugarcane and peanuts and early post-emergence control of certain annual grass and broadleaf weed in peanuts and sugarcane	
Date of registration/approval:	21 June 2016	
Product registration no.:	82379	
Label approval no.:	82379/105606	

Application no.:	102875	
Product name:	Biofilm Termite Barrier Systems	
Active constituent/s:	1 g/kg bifenthrin	
Applicant name:	The Trustee for Termicide Pest Control Trust	
Applicant ACN:	N/A	
Summary of use	For the protection of structures from concealed termite entry	
Date of registration/approval:	22 June 2016	
Product registration no.:	81353	
Label approval no.:	81353/102875	

Application no.:	102902	
Product name:	Hy-Clor We Make Water Fun! Li'l Pools Mini Tablets For Small Pools	
Active constituent/s:	900 g/kg available chlorine (Cl) present as trichloroisocyanuric acid	
Applicant name:	Hy-Clor (Australia) Pty Ltd	
Applicant ACN:	000 655 381	
Summary of use	For control of bacteria, viruses and algae in swimming pools	
Date of registration/approval:	22 June 2016	
Product registration no.:	81362	
Label approval no.:	81362/102902	

Application no.:	58104	
Product name:	Kendon Carbaryl Wettable Granule Insecticide	
Active constituent/s:	800 g/kg carbaryl (an anti-cholinesterase compound)	
Applicant name:	Kendon Plant Care Pty Ltd	
Applicant ACN:	065 737 948	
Summary of use	For the control of certain insects in fruit and vegetables crops and for certain other uses as specified 	
Date of registration/approval:	24 June 2016	
Product registration no.:	68322	
Label approval no.:	68322/58104	

Application no.:	106142	
Product name:	Double Alpha MCPA 500 Selective Herbicide	
Active constituent/s:	500 g/L MCPA present as the dimethylamine salt	
Applicant name:	Alpha Crop Protection Pty Ltd	
Applicant ACN:	165 653 047	
Summary of use	For selective control of broadleaf weeds in cereals, field peas, linseed, pastures, 
sugarcane and turf	
Date of registration/approval:	24 June 2016	
Product registration no.:	82592	
Label approval no.:	82592/106142	

Application no.:	106290	
Product name:	Atlas Outdoor Fogger	
Active constituent/s:	1.1 g/kg esbiothrin, 0.5 g/kg permethrin	
Applicant name:	Pascoe's Pty Ltd	
Applicant ACN:	055 220 463	
Summary of use	For the control of certain insects around the home and garden	
Date of registration/approval:	24 June 2016	
Product registration no.:	82630	
Label approval no.:	82630/106290	

Application no.:	105281	
Product name:	WeedPro 360 BIO Herbicide	
Active constituent/s:	360 g/L glyphosate present as the isopropylamine salt	
Applicant name:	PCT Holdings Pty Ltd	
Applicant ACN:	099 023 962	
Summary of use	For the control of a range of annual, perennial and aquatic weeds	
Date of registration/approval:	24 June 2016	
Product registration no.:	82251	
Label approval no.:	82251/105281	

Application no.:	104562	
Product name:	AQ 200 Aquatic Herbicide	
Active constituent/s:	200 g/L diquat present as diquat dibromide monohydrate 	
Applicant name:	Aquatic Site Maintenance Pty Ltd	
Applicant ACN:	105 824 164	
Summary of use	For the control of a range of broadleaf weeds in aquatic areas	
Date of registration/approval:	27 June 2016	
Product registration no.:	81984	
Label approval no.:	81984/104562	

Application no.:	105054	
Product name:	Enforcer 242 Herbicide	
Active constituent/s:	420 g/L MCPA present as the potassium salt, 26 g/L picloram present as the potassium salt	
Applicant name:	Adama Australia Pty Limited	
Applicant ACN:	050 328 973	
Summary of use	For the control of climbing buckwheat, common sowthistle, skeleton weed,
capeweed, doublegee and other broadleaf weeds in winter cereals and linseed crops	
Date of registration/approval:	27 June 2016	
Product registration no.:	82122	
Label approval no.:	82122/105054	

Application no.:	104026	
Product name:	Brunnings Trade Ready to Use Weed Kill	
Active constituent/s:	7.2 g/L glyphosate present as the isopropylamine salt	
Applicant name:	Brunnings Garden Products Pty Ltd	
Applicant ACN:	050 655 760	
Summary of use	For the control of weeds in the home garden	
Date of registration/approval:	27 June 2016	
Product registration no.:	81772	
Label approval no.:	81772/104026	

Application no.:	104036	
Product name:	Conquest Amine 700 Dual Salt Selective Herbicide	
Active constituent/s:	700 g/L 2,4-d present as dimethylamine and diethanolamine salts	
Applicant name:	Conquest Crop Protection Pty Ltd	
Applicant ACN:	098 814 932	
Summary of use	For the control of broadleaf weeds in fallow before direct drilling or sowing of 
cereals and pastures; and in cereal crops, pastures, sugar cane, peanuts and 
non-agricultural areas as per the directions for use	
Date of registration/approval:	27 June 2016	
Product registration no.:	81776	
Label approval no.:	81776/104036	

Application no.:	103821	
Product name:	Smart Maxx 540 Herbicide	
Active constituent/s:	540 g/L glyphosate (present as the monoethanolamine salt)	
Applicant name:	Crop Smart Pty Ltd	
Applicant ACN:	093 927 961	
Summary of use	For the control of most emerged weeds and plants in situations	
Date of registration/approval:	28 June 2016	
Product registration no.:	81719	
Label approval no.:	81919/103821	

Application no.:	106370	
Product name:	Avobalance Plant Growth Regulator	
Active constituent/s:	250 g/L paclobutrazol 	
Applicant name:	Rotam Agrochemical Co., Ltd	
Applicant ACN:	N/A	
Summary of use	For reduction of vegetative growth in mango, stone fruit and apple trees	
Date of registration/approval:	29 June 2016	
Product registration no.:	82649	
Label approval no.:	82649/106370	

Application no.:	105583	
Product name:	Gardenline Extra Strength Weed & Feed For Lawns	
Active constituent/s:	3.5 g/L dicamba present as dimethylamine salt, 23 g/L MCPA present as the dimethylamine salt	
Applicant name:	Brunnings Garden Products Pty Ltd	
Applicant ACN:	050 655 760	
Summary of use	For the control of broadleaf weeds in wheat, oats, barley, cereal rye, triticale, linseed, grass pastures and turf	
Date of registration/approval:	29 June 2016	
Product registration no.:	82369	
Label approval no.:	82369/105583	

Application no.:	106378	
Product name:	Atlas Rose Spray	
Active constituent/s:	0.1 g/L tau-fluvalinate, 0.05 g/L muclobutanil	
Applicant name:	Pascoe’s Pty Ltd	
Applicant ACN:	055 220 463	
Summary of use	For the control of various insects and fungal diseases on roses and ornamentals. Systemic control of black spot, powdery mildew and rust. Kills aphids, thrips, caterpillars, budworm and mites on roses and ornamentals. Works via contact and stomach action	
Date of registration/approval:	29 June 2016	
Product registration no.:	82657	
Label approval no.:	82657/106378	

Application no.:	104370	
Product name:	eChem Ethephon 900 Growth Regulator	
Active constituent/s:	900 g/L ethephon (an anti-cholinesterase compound)	
Applicant name:	eChem (Aust) Pty Limited	
Applicant ACN:	089 133 095	
Summary of use	For crop thinning, loosening or ripening in various crops and for accelerating boll 
opening, defoliation and pre-conditioning before defoliation of cotton	
Date of registration/approval:	29 June 2016	
Product registration no.:	81899	
Label approval no.:	81899/104370	

Application no.:	106128	
Product name:	Genfarm Tebuthiuron 200 Herbicide	
Active constituent/s:	200 g/kg tebuthiuron	
Applicant name:	Landmark Operations Limited	
Applicant ACN:	008 743 217	
Summary of use	For control of brigalow regrowth, tea tree regrowth, mimoa pigra and certain problem wood weeds on grazing lands	
Date of registration/approval:	29 June 2016	
Product registration no.:	82582	
Label approval no.:	82582/106128	

Application no.:	106388	
Product name:	Atlas Garden Insect Spray	
Active constituent/s:	0.125 g/L imidacloprid	
Applicant name:	Pascoe’s Pty Ltd	
Applicant ACN:	055 220 463	
Summary of use	For the systemic control of various insect pests around the home garden	
Date of registration/approval:	30 June 2016	
Product registration no.:	82664	
Label approval no.:	82664/106388	
Application no.:	101730	
Product name:	Melpat Dinon 700 WG Fungicide	
Active constituent/s:	700 g/kg dithianon	
Applicant name:	Melpat International Pty Ltd	
Applicant ACN:	066 067 507	
Summary of use	For the control a range of diseases in pome fruit, stone fruit and grapevines	
Date of registration/approval:	30 June 2016	
Product registration no.:	80823	
Label approval no.:	80823/101730	

Application no.:	106377	
Product name:	Atlas White Spray Oil	
Active constituent/s:	19.46 g/L paraffin oil	
Applicant name:	Pascoe’s Pty Ltd	
Applicant ACN:	055 220 463	
Summary of use	For control of various scales, mites, mealy bugs, leafminers, whiteflies and aphids	
Date of registration/approval:	30 June 2016	
Product registration no.:	82656	
Label approval no.:	82656/106377	

Application no.:	106512	
Product name:	Sundew BattleaxePRO Roach Bait	
Active constituent/s:	0.5 g/kg fipronil	
Applicant name:	Sundew Solutions Pty Ltd	
Applicant ACN:	135 400 261	
Summary of use	For the control of cockroaches	
Date of registration/approval:	30 June 2016	
Product registration no.:	82708	
Label approval no.:	82708/106512	
3.	Variations of registration 
Application no:	106245	
Product name:	Ptsan 5 Sanitiser	
Active constituent/s:	250 g/L hydrogen peroxide, 50 g/L peroxyacetic acid	
Applicant name:	AJL8 Enterprises Pty Ltd	
Applicant ACN:	150 377 683	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘PERATEC 5 SANITISER’ to ‘PTSAN 5 SANITISER’	
Date of variation:	8 April 2016	
Product registration no.:	48906	
Label approval no.:	48906/106245	

Application no:	105860	
Product name:	Macro Protect Cleth 240 Herbicide	
Active constituent/s:	240 g/L clethodim	
Applicant name:	Macrofertil Australia Pty Ltd	
Applicant ACN:	166 370 976	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘RAVENSDOWN BLADE 240EC HERBICIDE’ to ‘MACRO PROTECT CLETH 240 HERBICIDE’	
Date of variation:	3 March 2016	
Product registration no.:	60717	
Label approval no.:	60717/105860	

Application no.:	101326	
Product name:	Fyfanon 440 EW Insecticide	
Active constituent/s:	440 g/L maldison (an anticholinesterase compound)	
Applicant name:	Cheminova Australia Pty Limited	
Applicant ACN:	110 199 169	
Summary of variation:	To modify uses for fruit fly	
Date of variation:	21 June 2016	
Label approval no.:	51150/101326	

Application no:	103561	
Product name:	Melpat Tribasic Liquid Flowable Copper Fungicide	
Active constituent/s:	190 g/L copper (CU) present as tribasic copper sulphate	
Applicant name:	Melpat International Pty Ltd	
Applicant ACN:	066 067 507	
Summary of variation:	To extend the uses into hazelnuts, pistachios and macadamias	
Date of variation:	22 June 2016	
Product registration no.:	67618	
Label approval no.:	67618/103561	

Application no.:	103780	
Product name:	Campbell Stanza WP Fungicide	
Active constituent/s:	462 g/kg prochloraz present as the manganese chloride complex	
Applicant name:	Colin Campbell (Chemicals) Pty Ltd	
Applicant ACN:	000 045 590	
Summary of variation:	To extend the use to control colletotrichum crown rot, stolon rot in non-fruiting strawberry
runners	
Date of variation:	22 June 2016	
Label approval no.:	69707/103780	

Application no:	106020	
Product name:	Crop Care Barrack 720 Fungicide	
Active constituent/s:	720 g/L chlorothalonil	
Applicant name:	Crop Care Australasia Pty Ltd	
Applicant ACN:	061 362 347	
Summary of variation:	To add additional pack sizes	
Date of variation:	29 June 2016	
Product registration no.:	53884	
Label approval no.:	53884/106020	

Application no.:	106072	
Product name:	Bollgard 3	
Active constituent/s:	Bacillus thuringiensis subsp. kurstaki delta endotoxins as produced by the Cry1Ac and
Cry2Ab genes and their controlling sequences. Bacillus thuringiensis strain AB88 exotoxin as produced by the Vip3A(a) gene and its controlling sequence	
Applicant name:	Monsanto Australia Ltd	
Applicant ACN:	006 725 560	
Summary of use	To change the name of the product from 'BOLLGARD III' to 'BOLLGARD 3', to extend use to Victoria, and to amend the planting window	
Date of registration/approval:	29 June 2016	
Product registration no.:	69656	
Label approval no.:	69656/106072	

Application no:	105301	
Product name:	Triclops Herbicide	
Active constituent/s:	600 g/L triclopyr present as the butoxyethyl ester	
Applicant name:	Crop Culture Pty Ltd	
Applicant ACN:	142 860 473	
Summary of variation:	To change the product name from ‘CROP CULTURE TRICLOPS HERBICIDE’ 
to ‘TRICLOPS HERBICIDE’, add an additional 10 L pack size and add uses	
Date of variation:	1 July 2016	
Product registration no.:	67456	
Label approval no.:	67456/105301	

Veterinary Chemical Products and Approved Labels 
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.
1.	Veterinary Products Based on Existing Active Constituents
Application no.:	51312	
Product name:	Apiguard Gel for Beehives	
Active constituent/s:	250 g/kg thymol 	
Applicant name:	Vita (Europe) Limited	
Applicant ACN:	N/A	
Summary of use	For use in beehives to control the parasitic mite, Varroa destructor, on honey bees.
This product must only be supplied in the event the Chief Plant Protection Officer of the Commonwealth declares an outbreak of varroa mite (Varroa destructor) in accordance with the Emergency Plant Pest Response Deed.
This product must only be used by persons authorised by the Chief Plant Protection Officer of the Commonwealth in accordance with the Emergency Plant Pest Response Deed in the event of a declared outbreak of varroa mite (Varroa destructor)	
Date of registration/approval:	29 June 2016	
Product registration no.:	65570	
Label approval no.:	65570/51312	

Application no.:	61891	
Product name:	READYSERVE Altrenogest Injection for Horses	
Active constituent/s:	50 mg/mL altrenogest	
Applicant name:	Ceva Animal Health Pty Ltd	
Applicant ACN:	002 692 426	
Summary of use	For the suppression of oestrus in normally cycling mares	
Date of registration/approval:	30 June2016	
Product registration no.:	69854	
Label approval no.:	69854/61891	
2.	Variations of registration 
Application no:	106959	
Product name:	Bexepril Flavoured 20 mg Tablets For Dogs	
Active constituent/s:	Each tablet contains 20 mg benazepril hydrochloride	
Applicant name:	Zoetis Australia Pty Ltd	
Applicant ACN:	156 476 425	
Summary of variation:	To change the distinguishing product name and the name that appears 
on the label from ‘FORTERIL FLAVOURED 20MG TABLETS FOR DOGS’ 
to ‘BEXEPRIL FLAVOURED 20MG TABLETS FOR DOGS’	
Date of variation:	8 June 2016	
Product registration no.:	69454	
Label approval no.:	69454/106959	

Application no:	106958	
Product name:	Bexepril Flavoured 5 mg Tablets For Dogs	
Active constituent/s:	Each tablet contains 5 mg benazepril hydrochloride	
Applicant name:	Zoetis Australia Pty Ltd	
Applicant ACN:	156 476 425	
Summary of variation:	To change the distinguishing product name and the name that appears on
the label from ‘FORTERIL FLAVOURED 5MG TABLETS FOR DOGS 
AND CATS’ to ‘BEXEPRIL FLAVOURED 5MG TABLETS FOR DOGS’	
Date of variation:	8 June 2016	
Product registration no.:	69456	
Label approval no.:	69456/106958	

Application no:	106960	
Product name:	Bexepril Flavoured 2.5 mg Tablets For Dogs	
Active constituent/s:	Each tablet contains 2.5 mg benazepril hydrochloride	
Applicant name:	Zoetis Australia Pty Ltd	
Applicant ACN:	156 476 425	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘FORTERIL FLAVOURED 2.5MG TABLETS FOR DOGS’ to ‘BEXEPRIL FLAVOURED 2.5MG TABLETS FOR DOGS’	
Date of variation:	8 June 2016	
Product registration no.:	69455	
Label approval no.:	69455/106960	

Application no:	106963	
Product name:	Rheumocam 20 mg/mL Injection for Horses	
Active constituent/s:	meloxicam 20 mg/mL	
Applicant name:	Zoetis Australia Pty Ltd	
Applicant ACN:	156 476 425	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘M-ELOXYN 20 MG/ML INJECTION FOR HORSES’ to 
‘RHEUMOCAM 20 MG/ML INJECTION FOR HORSES’	
Date of variation:	8 June 2016	
Product registration no.:	69089	
Label approval no.:	69089/106963	

Application no:	106964	
Product name:	Rheumocam 20 mg/mL Solution for Injection	
Active constituent/s:	meloxicam 20 mg/mL	
Applicant name:	Zoetis Australia Pty Ltd	
Applicant ACN:	156 476 425	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘M-ELOXYN 20 MG/ML SOLUTION FOR INJECTION’ to ‘RHEUMOCAM 20 MG/ML SOLUTION FOR INJECTION’	
Date of variation:	8 June 2016	
Product registration no.:	67935	
Label approval no.:	67935/106964	

Application no:	106965	
Product name:	Rumifert Mineral Bolus For Cattle	
Active constituent/s:	Each bolus contains 13,400 mg copper, 500 mg cobalt, 300 mg selenium	
Applicant name:	Bimeda (Australia) Pty Limited	
Applicant ACN:	058 196 508	
Summary of variation:	To change the distinguishing product name and the name that appears on the label from ‘COSECURE NUTRITIONAL SUPPLEMENT FOR CATTLE’ to ‘RUMIFERT MINERAL BOLUS FOR CATTLE’	
Date of variation:	8 June 2016	
Product registration no.:	48197	
Label approval no.:	48197/106965	

Application no.:	100910	
Product name:	Avenge Pour-On Lousicide for Sheep	
Active constituent/s:	35 g/L imidacloprid	
Applicant name:	Bayer Australia Ltd (Animal Health)	
Applicant ACN:	000 138 714	
Summary of variation:	To add use in prevention of blow fly (Lucilia cuprina) strike up to 10 weeks	
Date of variation:	24 June 2016	
Product registration no.:	62598	
Label approval no.:	62598/100910	

Application no.:	101478	
Product name:	Improvest for Male Pigs	
Active constituent/s:	Each 2 mL dose provides minimum 300 μg/2 mL GnRF-protein conjugate	
Applicant name:	Zoetis Australia Pty Ltd	
Applicant ACN:	156 476 425	
Summary of variation:	To reduce the in-use shelf life from 30 to 28 days and reduce the shelf life to 
24 months	
Date of variation:	30 June 2016	
Product registration no.:	70058	
Label approval no.:	70058/101478	

Approved Active Constituents
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has approved or varied the relevant particulars or conditions of the approval of the following active constituents, with effect from the dates shown.
1.	active consitutent
Application no.:	104475	
Active constituent/s:	Fluquinconazole	
Applicant name:	4 Farmers Australia Pty Ltd	
Applicant ACN:	160 092 428	
Summary of use:	For use in agricultural chemical products	
Date of approval:	24 June 2016	
Approval no.:	81952	

Application no.:	60592	
Active constituent/s:	Bixafen	
Applicant name:	Bayer Cropscience Pty Ltd	
Applicant ACN:	000 226 022	
Summary of use:	For use in agricultural chemical products	
Date of approval:	28 June 2016	
Approval no.:	69362	

Application no.:	104151	
Active constituent/s:	Metalaxyl	
Applicant name:	Industrias Quimicas Del Valles, S.A	
Applicant ACN:	N/A	
Summary of use:	For use in agricultural chemical products	
Date of approval:	29 June 2016	
Approval no.:	81846	

Application no.:	103199	
Active constituent/s:	Dodine	
Applicant name:	AgriNova New Zealand Limited T/A Gro-Chem	
Applicant ACN:	N/A	
Summary of use:	For use in agricultural chemical products	
Date of approval:	30 June 2016	
Approval no.:	81484	

Application no.:	104448	
Active constituent/s:	Dicamba	
Applicant name:	Syngenta Australia Pty Ltd	
Applicant ACN:	002 933 717	
Summary of use:	For use in agricultural chemical products	
Date of approval:	1 July 2016 	
Approval no.:	81932	

Cancellation of Registration and Approval at the Request of the Holder
At the request of the holder, the APVMA has cancelled the registration and the associated label approvals of the following products: 
Product no.	Product name	Approval holder	Date of effect	
59355	RUMI-BUFF NATURAL RUMINANT BUFFER BASED ON CALCIFIED SEAWEED	RABAR PTY LTD	27 June 2016	
59362	TYLOPHARM SOLUBLE TYLOSIN TARTRATE SOLUBLE POWDER	ABBEY LABORATORIES PTY LTD	27 June 2016	
69741	ABATAK LV LOW VOLUME ABAMECTIN BROAD SPECTRUM ANTIPARASITIC FOR SHEEP AND LAMBS	ABBEY LABORATORIES PTY LTD	27 June 2016	
68716	FLOW SURE ELECTROLYTE HARTMANN'S SOLUTION	ABBEY LABORATORIES PTY LTD	27 June 2016	
68717	FLOW SURE CAL MILK FEVER INJECTION	ABBEY LABORATORIES PTY LTD	27 June 2016	
68718	FLOW SURE 0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION BP	ABBEY LABORATORIES PTY LTD	27 June 2016	
68719	FLOW SURE 4 IN 1 BALANCED MINERAL INJECTION	ABBEY LABORATORIES PTY LTD	27 June 2016	
55262	TIAMUPHARM SOLUBLE POWDER	ABBEY LABORATORIES PTY LTD	27 June 2016	
66147	ICS BUFFERING ADJUVANT	INNOVATIVE CHEMICAL SERVICES PTY LTD	27 June 2016	
66148	ICS HYBRID SPRAY ADJUVANT	INNOVATIVE CHEMICAL SERVICES PTY LTD	27 June 2016	
66149	ICS ESTERIFIED SEED OIL SPRAY ADJUVANT	INNOVATIVE CHEMICAL SERVICES PTY LTD	27 June 2016	
66150	ICS-GA GROWTH REGULATOR	INNOVATIVE CHEMICAL SERVICES PTY LTD	27 June 2016	
48838	COXISTAC BROAD SPECTRUM COCCIDIOCIDAL FEED ADDITIVE PREMIX	PHIBRO ANIMAL HEALTH PTY LIMITED	27 June 2016	
50996	POSISTAC 450 GROWTH PROMOTANT AND ANTICOCCIDIAL FEED PREMIX	PHIBRO ANIMAL HEALTH PTY LIMITED	27 June 2016	
50235	POSISTAC 60 GROWTH PROMOTANT AND ANTICOCCIDIAL FEED PREMIX	PHIBRO ANIMAL HEALTH PTY LIMITED	27 June 2016	

The following instructions set out how a person can deal with the cancelled products.
Supply
A person may supply or cause to be supplied products manufactured prior to 27 June 2016 at wholesale and retail level, until the 27 June 2017.
After 27 June 2017 it will be an offence against the Agvet Codes to have possession or custody of the products with the intention to supply, or to supply the products.
Use
A person may continue to use the products according to its label instructions until 27 June 2017.
Any person who possesses, has custody of, uses, or otherwise deals with the listed products in accordance with the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have custody of, use or otherwise deal with the products after the registration has been cancelled until 27 June 2017.
The supply and use of the products must be in accordance with the conditions of registration or approval, including any conditions relating to the shelf life or expiry date.
It is an offence to possess, have custody of, use, or deal with the products listed in the table in a manner that contravenes the above instructions.
APVMA Contact
For any enquiries or further information about this matter, please contact:
Chemical Review
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
SYMONSTON ACT 2609
Phone:	+61 2 6210 4749
Fax:	+61 2 6210 4776
Email:	chemicalreview@apvma.gov.au 

Cancellation of Label Approval at the Request of the Holder
At the request of the holder, the APVMA has cancelled the following label approval:
Product no.	Product name	Holder	Cancelled Label Approvals	Date of effect	
46534	REGLONE NON-RESIDUAL HERBICIDE	SYNGENTA AUSTRALIA PTY LTD	46534/103283	27 June 2016	
The following instructions set out how a person can deal with the product bearing a cancelled label.
Supply
A person may supply or cause to be supplied product bearing a cancelled label manufactured prior to 27 June 2016 at wholesale and retail level, until 27 June 2017.
After 27 June 2017 it will be an offence against the Agvet Codes to have possession or custody of the product bearing a cancelled label with the intention to supply, or to supply the product bearing a cancelled label.
Use
A person may continue to use the product bearing a cancelled label according to its label instructions until 
27 June 2017.
Any person who possesses, has custody of, uses, or otherwise deals with the listed product bearing a cancelled label in accordance with the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have custody of, use or otherwise deal with the product bearing a cancelled label after the approval has been cancelled until 27 June 2017.
The supply and use of the product bearing a cancelled label must be in accordance with the conditions of registration or approval, including any conditions relating to the shelf life or expiry date.
It is an offence to possess, have custody of, use, or deal with the product bearing a cancelled label listed in the table in a manner that contravenes the above instructions.
APVMA Contact
For any enquiries or further information about this matter, please contact:
Chemical Review
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
SYMONSTON ACT 2609
Phone:	+61 2 6210 4749
Fax:	+61 2 6210 4776
Email:	chemicalreview@apvma.gov.au 
New Agricultural Active Constituent Mandestrobin
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a new active constituent, mandestrobin.
Mandestrobin is a white, crystalline powdery solid (98.8%) with no odour, a melting point of 102°C and a boiling point of 296°C. Its solubility in water is 15.8 mg/L at 20°C.
Common Name:	Mandestrobin	
IUPAC Name:	(RS)-2-Methoxy-N-methyl-2-[α-(2,5-xylyloxy)-o-tolyl] acetamide.	
CAS Name:	2-[(2,5-dimethylphenoxy)methyl]-α-methoxy-N-methylbenzene acetamide.	
CAS Registry Number:	173662-97-0	
Manufacturer’s Codes:	S-2200	
Minimum Purity:	940 g/kg	
Molecular Formula:	C19H23NO3	
Molecular Weight:	313.39	

Structure:

	

	
Chemical Family:	Strobilurin fungicides	
Mode of Action:	Mandestrobin inhibits mitochondrial fungal respiration by binding to the QoI-centre site on cytochrome b. This inhibits electron transfer between cytochrome b1 and cytochrome c1. The inhibition then disrupts the energy cycle within the fungus by halting the production of ATP. As S-2200 is a racemic mixture of two stereoisomers (S-isomer and R-isomer) it is demonstrated that only the R-isomer has fungicidal activity.	

Summary of the APVMA’s Evaluation of Mandestrobin Active Constituent
The APVMA has evaluated the chemistry aspects of mandestrobin active constituent (manufacturing process, quality control procedures, batch analysis results and analytical methods) and found them to be acceptable. 
On the basis of the data provided, and the toxicological assessment, it is proposed that the following APVMA Active Constituent Standard be established for mandestrobin active constituent:
Constituent	Specification	Level	
Mandestrobin	Mandestrobin	940 g/kg minimum	
Other compounds of toxicological significance are not expected to occur in mandestrobin TGAC.
The Office of Chemical Safety (OCS) has completed a toxicological evaluation of mandestrobin.
The Acceptable Daily Intake for mandestrobin was established at 0.19 mg/kg bw/d using the NOEL of 19.2 mg/kg bw/d from a 52 week dietary study in dogs and applying a 100–fold safety factor, based on dark liver, centrilobular hepatocyte hypertrophy and pigmented hepatocytes in both sexes at doses of 92.0 mg/kg/d.
An acute reference dose was not established for mandestrobin, as it was not considered likely to present an acute hazard to humans. 
Based on the toxicity profile of the active constituent and the product, the Delegate of the Secretary of the Department of Health made a Delegate-only decision, listing mandestrobin in Schedule 5 of the SUSMP with an exemption cut-off for preparations containing 25 per cent or less of mandestrobin.
The OCS has indicated that there are no objections on toxicological grounds to the approval of the active constituent mandestrobin.
The APVMA accepts the findings and recommendations of its advisers on these criteria.
The APVMA is satisfied that the proposed importation and use of mandestrobin would not be an undue toxicological hazard to the safety of people exposed to it during its handling and use.
Making a Submission
In accordance with sections 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for approval of Mandestrobin should be granted. Submissions should relate only to matters that the APVMA is required by legislation to consider in deciding whether to grant the approval. These grounds include chemistry and manufacture, and toxicity. Submissions should state the grounds on which they are based. Comments received outside these grounds cannot be considered by the APVMA. 

Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post. A summary of relevant comments and the APVMA’s response will be published on the APVMA website. 
When making a submission please include:
•	contact name
•	company or group name (if relevant)
•	postal address
•	email address (if available)
•	the date you made the submission.
All personal and confidential commercial information (CCI) material contained in submissions will be treated confidentially. 
Written submissions on the APVMA’s proposal to grant approval for mandestrobin that relate to the grounds for approval should be addressed in writing to: 
Director Chemistry and Manufacture
Scientific Assessments and Chemical Review Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Phone:	+61 2 6210 4936
Fax:	+61 2 6210 4840
Email:	chemistry@apvma.gov.au 

New Agricultural Chemical Product Containing a New Agricultural Active Constituent mandestrobin in Intuity Fungicide 
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Sumitomo Chemical Australia Pty Limited for registration of a new product Intuity Fungicide containing the new active constituent mandestrobin. The product is proposed to be registered for use on stone fruit.
Particulars of The Application
Proposed product name(s):	INTUITY fungicide	
Applicant company:	Sumitomo Chemical Australia Pty Limited	
Name of active constituent:	Mandestrobin	
Signal heading:	Not required (unscheduled as the product contains 25% or less mandestrobin)	
Summary of proposed use:	For the control of blossom blight and brown rot in stone fruit	
Pack sizes:	1 L, 5 L, 10 L and 20 L	
Withholding period:	Harvest: Do not harvest fruit for 7 days after application
Grazing: Do not allow grazing of inter-rows in stone fruit orchards	
Summary of the APVMA’s evaluation of INTUITY Fungicide in accordance with THE REQUIREMENTS OF SECTION 5A, 5B and 5C of the Agricultural and Veterinary Chemicals Code (the ‘Agvet Code’), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994
1.	The APVMA has evaluated the application and in its assessment in relation to whether the safety criteria have been met in accordance with the definition set out in sections 5A of the Agvet Code, and proposes to determine that:
(i)	The APVMA is satisfied that the proposed use of INTUITY Fungicide would not be an undue hazard to the safety of people exposed to it during its handling and use.
The absorption, distribution, metabolism and elimination of mandestrobin were investigated in rats. Mandestrobin is rapidly absorbed and then distributed to organs. There was no evidence of accumulation into the tissues. Mandestrobin was extensively metabolised and rapidly excreted, mainly in the faeces via the bile.
Based on the findings of the acute toxicological studies evaluated, mandestrobin is of low acute oral toxicity, low acute dermal toxicity, and low acute inhalational toxicity in rats. Mandestrobin was a moderate eye irritant in rabbits, but was not a skin irritant in rabbits and was non-sensitising in guinea pigs by the guinea pig maximisation test method. 
Repeat dose studies with mandestrobin have been conducted in rats, mice and dogs. The common toxicological effects in all species include reductions in body weight/body weight gain, liver enlargement and an increased incidence and severity of histopathological changes in the liver. 
Mandestrobin was not genotoxic in several in vitro and in vivo studies. There was no evidence of treatment related carcinogenicity in mice or rats. Reproductive and developmental studies indicated that mandestrobin was not a reproductive or developmental toxicant. There was no evidence of immunotoxicity following 28 days of dietary exposure and overall the weight of evidence indicated that mandestrobin was not neurotoxic.
Based on the findings of the acute toxicological studies evaluated, the product Intuity Fungicide has low acute oral, dermal and inhalational toxicity in rats, is not a skin or eye irritant in rabbits, and is not a skin sensitiser in guinea pig (Buehler method). 
Intuity Fungicide will be professionally used for commercial situations, and farmers and their employees will be the main users of the product. Workers may be exposed to the product when opening containers, mixing/loading/application, cleaning up spills, maintaining equipment and entering treated areas. The main routes of exposure to the product will be dermal, inhalational and ocular exposure.
In the absence of exposure data for the proposed mode of application, the Pesticide Handler Exposure Database (PHED) Surrogate Exposure Guide was used to estimate exposure. 
Exposure to the product when preparing and using the spray for airblast application was at an acceptable level when a single layer of personal protective equipment (PPE) and gloves are used by workers during mixing/loading and application of the product. Based on the risk assessment, First Aid Instructions and Safety Directions have been recommended for the product label.
Based on an assessment of the toxicology, it was considered that there should be no adverse effects on human health from the use of Intuity Fungicide when used in accordance with the label directions.
The APVMA is satisfied that the proposed use of INTUITY FUNGICIDE containing the active constituent mandestrobin is not likely to be harmful to human beings if used according to the product label directions.
(ii)	The APVMA is satisfied that the proposed use of INTUITY Fungicide will not be an undue hazard to the safety of people using anything containing its residues.
The product will be used as a foliar spray on stone fruit. The APVMA Residues and Trade Section has evaluated the residues aspects of the proposed product and has recommended amendments to the APVMA MRL Standard for mandestrobin. Dietary intake modelling has shown the expected chronic dietary exposures to mandestrobin are below the Acceptable Daily Intake (ADI) level. Recommendations in regard to the withholding period and protection statements for livestock have been included on the label. 
The APVMA is satisfied that the proposed use of Intuity Fungicide containing the active constituent mandestrobin is not likely to be harmful to safety of people using anything containing its residues if used according to the product label. 
(iii)	The APVMA is satisfied that the proposed use of the new product INTUITY fungicide containing the active constituent mandestrobin, would not be likely to have an unintended effect that is harmful to animals, plants or things or the environment.
Data provided in support of the proposed use have been assessed and it is concluded that the risks to the environment from this use are acceptable provided that the draft label is updated to meet current spray drift requirements. 
Photolysis on soils is unlikely to be a major degradation route. In aerobic soils, the R-isomer degraded more slowly than the S-isomer with geometric mean half-lives (n = 6) of 105 days and 73.4 days respectively. The major soil metabolites identified were not persistent with half-lives in aerobic soil of 41 days or less. Despite individual laboratory soil half-lives up to 322 days, in field dissipation trials mandestrobin dissipated rapidly with half-lives of 8.3 days or less. Residues were primarily restricted to the top 10 cm of soil and no major metabolites (>10%) were identified. In anaerobic soil mandestrobin showed only limited degradation.
Mandestrobin has low to medium mobility in soils. There was no evidence of any pH or percentage of organic carbon dependence. Two metabolites were shown to be more mobile than mandestrobin. In water, mandestrobin is hydrolytically stable in the environmental pH range, however, it may be expected to photodegrade (DT50 <1 week).
When released to water, mandestrobin may be expected to partition to the sediments where degradation is likely to be slow. 
Mandestrobin is not expected to bioconcentrate in organisms. Mandestrobin is practically non-toxic to birds through acute oral and short term dietary testing. Mandestrobin is highly toxic to fish, highly toxic to aquatic invertebrates based on testing to the mysid shrimp, and moderately toxic to algae. The major metabolites were all less toxic to aquatic organisms than the parent compound.
Mandestrobin was shown to not be of concern to bees, non-target arthropods, earthworms, soil micro-organisms, and non-target terrestrial plants (subject to appropriate downwind buffer zones).
Based on the tested environmental effects of the active constituents and the end-use product, and its proposed use pattern, the environmental risk was determined to be acceptable. Risk mitigation measures (downwind buffer zones) have been recommended to protect the aquatic environment.
The APVMA is satisfied that the use of Intuity Fungicide would not be likely to have an unintended effect that is harmful to animals, plants or things or the environment
2.	The APVMA has evaluated the application and in its assessment in relation to whether the efficacy criteria have been met in accordance with the definition set out in section 5B of the Agvet Code, and proposes to determine that:
(i)	In relation to its assessment of efficacy under section 5B, the APVMA is satisfied that data from trials supporting the efficacy of the product adequately demonstrate that, if used according to the product label directions, the product is effective for its proposed use in stone fruit for the control of blossom blight and brown rot.
3.	The APVMA has evaluated the application and in its assessment in relation to whether the trade criteria have been met in accordance with the definition set out in section 5C of the Agvet Code, and proposes to determine that:
(ii)	The APVMA is satisfied that the proposed use of INTUITY FUNGICIDE would not adversely affect trade between Australia and places outside Australia as identified risks can be mitigated with sufficient label instructions given stone fruit are the only crop to be approved for use.
Export of treated produce containing finite (measurable) residues of mandestrobin may pose a risk to Australian trade in situations where (i) no residue tolerance (import tolerance) is established in the importing country or (ii) where residues in Australian produce are likely to exceed a residue tolerance (import tolerance) established in the importing country. 
Mandestrobin MRLs have not been established by Codex or any other international authority, other than Japan and Canada. Stone fruit is a major export commodity. The proposed use of mandestrobin on stone fruit is expected to result in finite residues. The proposed use of Intuity Fungicide on stone fruit therefore may potentially cause an undue risk to international trade if no mitigation measures are implemented.

The following label advice relating to trade has been proposed:
Treated crops for export to particular destinations outside Australia may require a longer interval before harvest to comply with residues standards of importing countries. Please contact your industry body, exporter or Sumitomo Chemical Australia before using INTUITY FUNGICIDE.
The relevant industry groups should provide comment on the perceived level of risk and whether any industry-initiated strategies are required to manage the risk prior to a recommendation being made on the trade criteria.
FuRther Information
A Public Release Summary (PRS) of the evaluation of this product is available from the APVMA website’s ‘Public Consultation’ page or by contacting the APVMA via the details listed below.
Making a Submission
In accordance with section 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether INTUITY FUNGICIDE should be registered. Submissions should relate only to matters that the APVMA is required by legislation to take into account in deciding whether to grant the application. These grounds include occupational health and safety, chemistry and manufacture, residues, safety and first aid, environmental fate and toxicity, efficacy or trade. Submissions should state the grounds on which they are based. Comments received outside these grounds cannot be considered by the APVMA.
Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post. 
Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and in determining appropriate conditions of registration and product labelling.
When making a submission please include:
•	contact name
•	company or group name (if relevant)
•	email or postal address
•	the date you made the submission.
All personal and confidential commercial information (CCI) material contained in submissions will be treated confidentially.
Written submissions on the APVMA’s proposal to grant the application for registration that relate to the grounds for registration should be addressed in writing to: 
Case Management and Evaluation 
Registration Management and Evaluation
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Phone:	+61 2 6210 4700
Fax:	+61 2 6210 4776
Email:	enquiries@apvma.gov.au 

Licensing of Veterinary Chemical Manufacturers
Pursuant to Part 8 of the Agricultural and Veterinary Chemical Codes scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has taken action, with respect to the licensing of the following veterinary chemical manufacturers, with effect from the dates shown.
For a comprehensive listing of all licensed manufacturers please see the APVMA’s website www.apvma.gov.au.
1.	NEW LICENCES
The APVMA has issued the following licences under subsection 123(1) of the Agricultural and Veterinary Chemicals Code [the Agvet Code]
alpha chemicals pty ltd	LICENCE NO: 2237	
ACN: 001 174 741
18 Inman Road
CROMER NSW 2099	Product Types:*	
	•	Category 2: Liquids (topical)	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, chemical synthesis, formulation including blending, filling, packaging, labelling, analysis and testing (physical and chemical), storage and release for supply	
	Licence Issued: 6 June 2016	
2.	CHANGES TO EXISTING LICENCES
The APVMA has issued the following licences under subsection 123(1) of the Agricultural and Veterinary Chemicals Code [the Agvet Code
LIPA PHARMACEUTICALS LTD	LICENCE NO: 2140	
ACN: 070 106 526
21 Reaghs Farm Road
MINTO NSW 2566	Product Types: *	
	•	Category 2: tablets, capsules, creams and lotions, liquids 
•	Category 3: liquids and powders
•	Category 4: premixes	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, tableting, tablet coating, capsule filling from bulk, analysis and testing (physical, chemical and antibiotic assay), storage and release for supply	
	Amended Licence Issued: 15 June 2016	

THE STATE OF QUEENSLAND, ACTING THROUGH THE DEPARTMENT OF AGRICULTURE AND FISHERIES	LICENCE NO: 6175	
ABN: 66 934 348 189
Biosecurity Sciences Laboratory
Health and Food Sciences Precinct
39 Kessels Road
COOPERS PLAINS QLD 4108	Product Types: *	
	•	Category 6: Single step manufacture	
	Step(s) of Manufacture: Analysis and testing (serological, immunological, virological (vaccine potency and purity testing))	
	Amended Licence Issued: 15 June 2016	
Mavlab animal health pty ltd	LICENCE NO: 1104	
ACN: 164 339 637
29–33 Rowland Street
SLACKS CREEK QLD 4127	Product Types: *	
	•	Category 1: sterile products
•	Category 2: tablets, powders, granules, sprays, liquids and gels
•	Category 3: liquids, sprays and powders
•	Category 4: premixes and supplements	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, dry milling, filling, packaging, labelling, tableting, aseptic filling, granulation, sterilisation (heat and filtration), wet milling of powders, microbiological reduction treatment (filtration, heat and chemical), analysis and testing (physical), storage and release for supply	
	Amended Licence Issued: 16 June 2016	
Apex Laboratories Pty Ltd	LICENCE NO: 2119	
ACN:  000 397 240
61 Chivers Road
SOMERSBY NSW 2250	Product Types: *	
	•	Category 2: Tablets, creams/lotion, ointments, pastes, powders and liquids 	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, strip, blister or sachet packaging, dry milling, microencapsulation, granulation, tableting, tablet coating, analysis and testing (physical), storage and release for supply	
	Amended Licence Issued: 17 June 2016	

ensign laboratories proprietary limited	LICENCE NO: 2040	
ACN: 004 395 242
490–500 Wellington Road
MULGRAVE VIC 3170	Product Types: *	
	•	Category 2: sprays, suspensions and liquids
•	Category 3: liquids and sprays
•	Category 4: premixes and supplements	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, wet milling, filling, packaging, sachet packaging, labelling, aerosol filling from bulk, analysis and testing (physical, chemical, microbiological and antibiotic assay), storage and release for supply	
	Amended Licence Issued: 21 June 2016	
Troy Laboratories PTy Ltd	LICENCE NO: 1092	
ACN: 000 283 769
31–35 Glendenning Road
GLENDENNING NSW 2761	Product Types: *	
	•	Category 1: Sterile products and terminally sterilised ointments
•	Category 2: Tablets, creams/lotions, ointments, gels, pastes, powders, sprays, granules, suspensions and liquids
•	Category 3: Liquids and sprays
•	Category 4: Supplements	
	Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, granulation, dry milling, aseptic filling, filling, packaging, labelling, strip, blister or sachet packaging, tableting, sterilisation (heat and filtration), microbiological reduction treatment (filtration and chemical), analysis and testing (physical and chemical), storage and release for supply	
	Amended Licence Issued: 23 June 2016	
Curtin University of Technology	LICENCE NO: 6144	
ABN: 99 143 842 569
School of Pharmacy
Building 306
Curtin University
Kent Street
BENTLEY WA 6102	Product Types: *	
	•	Category 6: Single step manufacture	
	Step(s) of Manufacture: Analysis and testing (physical and chemical)	
	Amended Licence Issued: 23 June 2016	

Felton Grimwade & Bosisto’s Pty Ltd	LICENCE NO: 2053	
ACN: 004 809 161
61–81 Clarinda Road
OAKLEIGH SOUTH VIC 3167	Product Types: *	
	•	Category 2: Liquids	
	Step(s) of Manufacture: Formulation including blending, filling, packaging, labelling, analysis and testing (physical and chemical), storage and release for supply	
	Amended Licence Issued: 27 June 2016	
3.	LICENCE CANCELLATIONS
The APVMA has cancelled the following licences under subsection 127(1) of the Agricultural and Veterinary Chemicals Code [the Agvet Code].
Nil
4.	LICENCE SUSPENSIONS
The APVMA has suspended the following licences under subsection 127(1) of the Agricultural and Veterinary Chemicals Code [the Agvet Code].
Markitforce pty. ltd.	LICENCE NO: 6194	
ACN: 23 095 684 834
1/13 Childs Road
CHIPPING NORTON NSW 2170	Date Suspended: 6 June 2016 to 1 November 2016	
		
Charles i. f. e. proprietary limited	LICENCE NO: 6155	
ACN: 004 994 629
‘Berrybank Farm’
34 Hendersons Road
WINDERMERE VIC 3352	Date Suspended: 23 June 2016 to 21 June 2017	
		
5.	REVOCATION OF LICENCE CANCELLATION
The APVMA has revoked the cancellation of the following licences under subsection 127(7) of the Agricultural and Veterinary Chemicals Code [the Agvet Code].
Nil
6.	REVOCATION OF LICENCE SUSPENSION
The APVMA has revoked the suspension of the following licences under subsection 127(7) of the Agricultural and Veterinary Chemicals Code [the Agvet Code].
Nil
APVMA Contact
Manufacturing Quality and Licensing Section
Legal and Compliance Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone:	+61 2 6210 4899
Fax:	+61 2 6210 4813
Email:	mls@apvma.gov.au